14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KAVO CORUND HANDPIECE 2013
FDA 510(k)
FDA Class 2
·Dental
ELECTROPHYSIOLOGY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 15, 2025
D131 KIDS INFANT ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTM·May 20, 2026
COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·April 23, 2013
MUSTANG?
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code FGE·September 9, 2014
KAPPA 700 DR
FDA Adverse Event
Injury
·MEDTRONIC S.A.·Product code DXY·July 10, 2008
BD ULTRA FINE¿ INSULIN PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 12, 2019
D131 KIDS INFANT ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL.·Product code DTM·September 26, 2024
D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTM·June 18, 2019
D131 DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE
FDA Adverse Event
SORIN GROUP ITALIA·Product code DTM·February 3, 2016
KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE
FDA 510(k)
FDA Class 2
·Neurology
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012